Antibacterial compositions and method of using same

ABSTRACT

Antibacterial solution useful as a cleaning agent suitable for cutaneous use by humans or otherwise which is aqueous based, free of alcohol and surfactants and having a quaternary ammonium compound as its principal antimicrobial agent, a number of moisturizing agents and DMDM Hydantoin serving at least as a preservative.

RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 09/699,774filed on Oct. 30, 2000, and also claims benefit of U.S. ProvisionalPatent Application No. 60/163,982 filed Nov. 8, 1999, the disclosure ofwhich is hereby incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates to antibacterial solutions useful as a cleansingagent suitable for cutaneous use by humans, as well as for applicationto non-absorbent equipment surfaces. The solution is designed to beapplied directly to the surface which is to be cleaned without any needto rinse it off. The antimicrobial solution is aqueous based, is free ofsurfactants, alcohol or other skin-drying or odor producing ingredientsand contains a quaternary ammonium compound as its principalantimicrobial agent. The solution also contains a combination ofmoisturizing agents such as extracts of aloe vera, lavender andchamomile. Additionally, DMDM hydantoin is blended into the solution andacts at least as a preservative.

BACKGROUND

There are a large number of formulations for antibacterial cleansingsolutions which include the quaternary ammonium compound BenzalkoniumChloride. At least some of the benzalkonium chloride formulations alsomake use of DMDM Hydantoin (e.g. “Glydant XL 1000”) as a preservative inthe solution (see for example, U.S. Pat. No. 5,914,300, granted Jun. 22,1999 in the names of Fujiwara et al., which is assigned to LeverBrothers Company).

Although the antibacterial effect of benzalkonium chloride has beenrecognized by workers in this field, nevertheless, it is customary toinclude materials in the cleaning solution such as surfactants and/oralcohols to provide a significant degree of the desired cleansing andantibacterial effects. In addition, in most instances, fragrances areadded to the composition as well to provide supposedly desirablecharacteristics to the product.

It has been found, however, that a highly effective and desirableantibacterial cleansing solution which does not require rinsingpreferably is formulated free of fragrance, alcohol and surfactants. Theundesirable drying effect of alcohol on the skin is avoided while, atthe same time, providing an aqueous-based, substantially residue-free,odor-free, effective antibacterial cleansing solution. The solution maybe applied as a spray or liquid or it may be saturated in a medium suchas an absorbent gauze or other fabric (e.g. a towelette) which is usedas a “wipe” on the skin or surface to be cleaned.

An exemplary formulation includes a water phase, a principal activephase, a preservative phase which also exhibits antibacterial effectsand a moisturizing phase.

STATEMENT OF INVENTION

It is an object of the present invention to provide a novel, effectiveanti-bacterial cleansing solution containing only ingredients which arespecifically selected as non-irritating, non-drying and beneficial tothe skin. At the same time, it has been found that such a cleansingsolution can be formulated so as to be an effective anti-bacterialcleanser for non-porous equipment and other surfaces such as may beencountered in environments such as medical treatment, food handling orotherwise, where the presence of bacteria would be a concern.

With these objectives in mind, an effective anti-bacterial cleaningsolution has been developed which is alcohol-free, surfactant-free andodor-free and comprises a quaternary ammonium compound in aqueoussolution as its principal antimicrobial agent. The solution alsocontains a combination of moisturizing agents such as extracts of aloevera, lavender and chamomile. Additionally, DMDM hydantoin is blendedinto the solution and acts at least as a preservative.

Certain preservatives known to be useful in liquid skin cleansers havebeen described as effective as preservatives because they exhibitantibacterial (and antifungal) effects themselves. It is believed thatthe preservative DMDM Hydantoin is one such preservative which not onlyprovides an antibacterial effect itself but, under appropriateconditions, enhances the antibacterial effect of the principalantibacterial agent, benzalkonium chloride, when the two are combined inaqueous solution as described herein.

The principal antibacterial agent (benzalkonium chloride) can be presentat a level of from about 0.1% to about 5% by weight, typically fromabout 0.5% to about 1.5%. The level is selected to provide the desiredlevel of antibacterial activity and can be modified within the indicatedranges as desired.

The stated moisturizing agents (extracts of aloe vera, chamomile andlavender) can be present at a level of about 0.1% to about 5% by weightas a group. The principal preservative compound (DMDM Hydantoin) can bepresent at a level of about 0.1% to about 2% by weight. The remainder ofthe solution is made up of sterile water.

As a general proposition, a suitable antibacterial cleansing solutionshould be stable and should not deteriorate over a period of time undernormal anticipated storage conditions. Further desirable attributes arethat the solution should be relatively free of constituents whichsensitize or irritate human skin. While a large percentage of thesolution constituents are relatively inactive or inert, and serve mainlyto carry or permit spreading the active ingredients, it is desirablethat appropriate moisturizing or hydrating ingredients be present inorder to facilitate penetration of the solution, at least to someextent, into the upper skin layer. To that end, the indicatedmoisturizing agents are included.

While the invention will be described in connection with a particularpreferred embodiment as set forth hereinafter, it should be recognizedthat various modifications as may be apparent to persons skilled in theart also may be made without departing from the invention.

DETAILED DESCRIPTION

In its principal application, the inventive formulation is intended tobe applied either directly or indirectly to the skin. Where a sprayapplicator is used, the solution is sprayed onto each hand (or skinsurface which is to be cleansed) and thereafter the skin is hand rubbedgently until it is dry. Where a towelette soaked with the anti-bacterialsolution is employed, the towelette is rubbed over the surface to becleansed and transfers the solution to the surface, where it is allowedto dry in situ. The presence of the moisturizing agents, along with theabsence of other objectionable residues or odors, leaves the skin clean,disinfected and pleasing to the touch.

The cleansing solution according to the present invention has beentested on humans and has been found to be non-irritating and effectiveas desired. The results of tests are set forth below.

Irritation and Sensitization Tests

Fifty-five subjects, male and female, ranging in age from 18 to 76years, were selected for this evaluation. Fifty subjects completed thisstudy. The remaining subjects discontinued their participation forvarious reasons unrelated to the study or the material tested. Thesubjects were selected on the basis, among other things, of the absenceof any visible skin disease which might be confused with skin reactionsfrom the test material, as well as avoidance of use of topical orsystemic steroids and/or antihistamines for several days prior to studyinitiation.

The upper back between the scapulae served as the test area. Prior tothe initiation of this study, towelette material was cut into I″×¾pieces. These samples were then placed over the gauze portion of anadhesive dressing and moistened with approximately 0.2 ml of testsolution. When applied to the test site, this patch formed asemi-occlusive patch.

This procedure was followed three times per week: Monday, Wednesday andFriday, for a total of ten applications. If a participant was unable toreport for an assigned test day, one makeup day was permitted. The testsite was marked to ensure the continuity of patch application.Participants were instructed to remove the patch after 24 hours. Thesite was evaluated just prior to reapplication.

If a test site exhibited a moderate (2+) reaction (see below for key)during the Induction Phase, application would be moved to an adjacentarea. Applications would be discontinued for the remainder of this testphase, if a moderate (2+) reaction was observed on this new test site.Applications would also be discontinued if a marked (3+) reaction wasnoted.

Rest periods consisted of twenty-four hours following each Tuesday andThursday removal, and forty-eight hours following each Saturday removal.At the conclusion of a rest period of approximately fourteen daysfollowing the tenth application, a challenge patch was applied to theoriginal site and to a virgin site. These sites were evaluated attwenty-four and forty-eight hours after application. The volar forearmserved as the virgin test site.

Evaluation Key

-   0—No visible reaction-   1+—Mild erythema-   2+—Well-defined erythema-   3+—Erythema and edema-   4+—Erythema and edema with vesiculation and ulceration

INDIVIDUAL TEST RESULTS INDUCTION PHASE Original Virgin Su Site Site No1 2 3 4 5 6 7 8 9 10 24 48 24 48 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 00 0 0 0 0 0 0 0 0 0 3 0 0 0 0 T* DID NOT COMPLETE STUDY 4 0 0 0 0 0 0 00 0 0 0 0 4 0 5 0 0 0 0 0 00 0 0 0 0 0 0 5 0 6 0 0 0 0 0 0 0 0 0 0 0 0 60 7 0 0 0 0 0 0 0 0 0 0 0 0 7 0 8 0 0 0 0 0 0 0 0 0 0 0 8 0 9 0 0 0 0 00 0 0 0 0 0 0 9 0 10 0 0 0 0 0 0 0 0 0 0 0 0 10 0 11 0 0 0 0 0 0 0 0 0 00 0 11 0 12 0 0 0 0 00 0 0 0 0 0 0 0 12 0 13 0 0 0 0 0 0 0 0 0 0 0 0 130 14 DID NOT COMPLETE STUDY 15 0 0 0 0 0 0 0 0 0 0 0 0 0 0 16 0 0 0 0 00 0 0 0 0 0 0 0 0 17 0 0 0 0 0 0 0 0 0 0 0 0 0 0 18 0 0 0 0 0 0 0 0 0 00 0 0 0 19 0 0 0 0 0 0 0 0 0 0 0 0 0 0 20 0 0 0 0 0 0 0 0 0 0 0 0 0 0 210 0 0 0 0 0 0 0 0 0 0 0 0 0 22 0 0 0 0 0 0 0 0 0 0 0 0 0 0 23 0 0 0 0 00 0 0 0 0 0 0 0 0 24 0 0 0 0 0 0 0 0 0 0 0 0 0 0 25 0 0 0 0 0 0 0 0 0 00 0 0 0 26 0 0 0 0 0 0 0 0 0 0 0 0 0 0 27 0 0 0 0 0 0 0 0 0 0 0 0 0 0 280 0 0 0 0 0 0 0 0 0 0 0 0 0 29 0 0 0 0 0 0 0 0 0 0 0 0 0 0 30 0 0 0 0 00 0 0 0 0 0 0 0 0 31 0 0 0 0 0 0 0 0 0 0 0 0 0 0 32 0 0 0 0 0 0 0 0 0 00 0 0 0 33 0 0 0 0 0 0 0 0 0 0 0 0 0 0 34 0 0 0 0 0 0 0 0 0 0 0 0 0 0 350 0 0 0 0 0 0 0 0 0 0 0 0 0 36 0 0 0 0 0 0 0 0 0 0 0 0 0 0 37 0 0 0 0 00 0 m 0 0 0 0 0 0 0 38 0 DID NOT COMPLETE STUDY 39 0 0 0 0 0 0 0 0 0 0 00 0 0 40 0 DID NOT COMPLETE STUDY 41 0 0 0 0 0 0 0 0 0 0 0 0 0 0 42 0 00 0 0 0 0 0 0 0 0 0 0 0 43 0 DID NOT COMPLETE STUDY 44 0 0 0 0 0 0 0 0 00 0 0 0 0 45 0 0 0 0 0 0 0 0 0 0 0 0 0 0 46 0 0 0 0 0 0 0 0 0 0 0 0 0 047 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 49 0 0 0 00 0 0 0 0 0 0 0 0 0 50 0 0 0 0 0 0 0 0 0 0 0 0 0 0 51 0 0 0 0 0 0 0 0 00 0 0 0 0 52 0 0 0 0 0 0 0 0 0 0 0 0 0 0 53 0 0 0 0 0 0 0 0 0 0 0 0 0 054 0 0 0 0 0 0 0 0 0 0 0 0 0 0 55 0 0 0 0 0 0 0 0 0 0 0 0 0 0 44 0 0 0 00 0 0 0 0 0 0 0 0 0 45 0 0 0 0 0 0 0 0 0 0 0 0 0 0 46 0 0 0 0 0 0 0 0 00 0 0 0 0 47 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 0 0 0 0 0 0 049 0 0 0 0 0 0 0 0 0 0 0 0 0 0 50 0 0 0 0 0 0 0 0 0 0 0 0 0 0 51 0 0 0 00 0 0 0 0 0 0 0 0 0 52 0 0 0 0 0 0 0 0 0 0 0 0 0 0 53 0 0 0 0 0 0 0 0 00 0 0 0 0 54 0 0 0 0 0 0 0 0 0 0 0 0 0 0 55 0 0 0 0 0 0 0 0 0 0 0 0 0 0T = TAPE REACTION m = ADDITIONAL MAKEUP FOR MEDICAL EMERGENCY

SUBJECT DATA SUBJECT NUMBER INITIALS AGE SEX 1 LA 74 F 2 JS 24 F 3 JM 28M 4 MB 67 F 5 AZ 76 M 6 JC 67 F 7 RS 64 M 8 ST 74 F 9 CS 56 F 10 SC 54 F11 CY 75 M 12 DR 33 F 13 MH 60 F 14 AS 70 F 15 AM 65 F 16 JM 70 M 17 GR21 F 18 CB 49 F 19 SS 62 F 20 SS 72 M 21 MS 66 F 22 AP 29 F 23 TP 73 M24 RL 50 F 25 RS 49 M 26 WW 36 M 27 SM 32 F 28 MS 60 F 29 LC 27 F 30 CL65 F 31 GF 65 F 32 RG 46 M 33 CR 40 F 34 MS 34 F 35 AH 38 F 36 lB 51 F37 DH 30 F 38 AC 19 F 39 TR 18 F 40 CS 18 M 41 GA 55 F 42 PM 53 F 43 DM26 F 44 MF 50 F 45 EL 50 F 46 JT 30 F 47 AN 74 F 48 LS 30 F 49 DS 28 M50 66 M 51 MM 41 F 52 CA 20 F 53 HV 65 F 54 GV 70 M 55 AS 36 M

The results of the tests show negative results (no irritation or othereffects) throughout the test intervals. Under the conditions of thesestudies, the towelette solution/material did not indicate any potentialfor dermal irritation and/or sensitization.

A sample of solution was submitted for microbiological evaluation andstandard time kill test at 30 seconds, 1 minute and 2 minutes.

A “Time Kill Study” was conducted to determine the antibacterialactivity of the sample solution after 30 seconds, 1 minute and 2 minutescontact time against Pseudomonas aeruginosa ATCC 15422, S. aureus ATOC6538 and E. coli ATCC 8739. Results showed that the sample solutionreduced bacteria count by 99.99% at 30 seconds contact time. It istypical for antimicrobial soap products to show a minimum of 99.99%reduction of the test organisms to substantiate antimicrobial claims.

CON- INITIAL CFU'S/ML OF PERCENT TACT CONCENT. TEST ORG. AT REDUC-SAMPLE TIME IN SAMPLE T = SEC. TION P. aerugino-sa 30 Sec. 2.7 × 10⁷Less than 10 99.99% ATTC 15442  1 Min. 2.7 × 10⁷ Less than 10 99.99%  2Min. 2.7 × 10⁷ Less than 10 S. aureus 30 Sec. 2.5 × 10⁷ Less than 1099.99% ATCC 6538  1 Min. 2.5 × 10⁷ Less than 10 99.99%  2 Min. 2.5 × 10⁷Less than 10 99.99% E. coli 30 Sec. 4.7 × 10⁷ Less than 10 99.99% ATCC8739  1 Min. 4.7 × 10⁷ Less than 10 99.99%  2 Min. 4.7 × 10⁷ Less than10 99.99%

The use of natural extracts in a water-based solution, which isfragrance, alcohol and surfactant-free, provides a desired moisturizingeffect, along with the necessary antibacterial effect and the cleansingsolution does not strip the skin of its natural oils.

While the invention has been described in terms of a preferredembodiment and preferred methods of use, it should be recognized thatvarious modifications may be made within the scope of the inventionwhich is pointed out in the following claims.

1. A skin or surface sanitizer composition prepared from a mixturecomprising: (A) at least one antibacterial agent consisting a quaternaryammonium compound; (B) a preservative; (C) a combination of moisturizingor hydrating agents; and (D) water; provided said composition does notcontain: (1) alcohol; and (2) surfactant.
 2. The composition of claim 1wherein said quaternary ammonium compound is benzalkonium chloride. 3.The composition of claim 1 wherein said preservative comprises DMDMHydantoin.
 4. The composition of claim 1 wherein said combination ofmoisturizing or hydrating agents comprises plant extracts.
 5. Thecomposition of claim 4 wherein said combination of moisturizing orhydrating agents include extracts selected from the group consisting ofaloe vera, lavender and chamomile.
 6. The composition of claim 1wherein, based on the total weight of said composition, saidantibacterial agent comprises from about 0.1 to about 5 weight percent,said preservative comprises about 0.1 to about 2 weight percent and saidcombination of moisturizing or hydrating agents comprises about 0.1 toabout 5 total weight percent.
 7. The composition of claim 2 wherein saidbenzalkonium chloride is present in an amount of from about 0.5 to about1.5 weight percent of said composition.
 8. The composition of claim 1wherein said combination of moisturizing agents are selected from thegroup consisting of aloe vera, lavender and chamomile.
 9. Thecomposition of claim 4 wherein said antibacterial agent comprisesbenzalkonium chloride.
 10. The composition of claim 5 wherein saidcombination of moisturizing agents is extracts of aloe vera andchamomile.
 11. The composition of claim 1 comprising: (A) from about 0.1to about 5 weight percent of at least one antibacterial agent; (B) about0.1 to about 2 weight percent of a preservative; (C) about 0.1 to about5 total weight percent of a combination of moisturizing or hydratingagents; and (D) water; wherein said at least one antibacterial agentcomprises benzalkonium chloride; said preservative comprises DMDMHydantoin and said combination of moisturizing agents comprises extractsof aloe vera, lavender and chamomile.
 12. A skin or surface sanitizercomposition prepared from a mixture comprising: (A) at least oneantibacterial agent a quaternary ammonium compound; (B) a preservative;(C) a combination of moisturizing or hydrating agents; and (D) water;provided said composition does not contain: (1) a skin-dryingingredient; and (2) surfactant.
 13. The composition of claim 12 whereinsaid skin-drying ingredient comprises alcohol.
 14. The composition ofclaim 12 wherein said quaternary ammonium compound is benzalkoniumchloride.
 15. The composition of claim 12 wherein said preservativecomprises DMDM Hydantoin.
 16. The composition of claim 12 wherein saidcombination of moisturizing or hydrating agents comprises plantextracts.
 17. The composition of claim 16 wherein said combination ofmoisturizing or hydrating agents include extracts selected from thegroup consisting of aloe vera, lavender and chamomile.
 18. Thecomposition of claim 12 wherein, based on the total weight of saidcomposition, said antibacterial agent comprises from about 0.1 to about5 weight percent, said preservative comprises about 0.1 to about 2weight percent and said combination of moisturizing or hydrating agentscomprises about 0.1 to about 5 total weight percent.
 19. The compositionof claim 14 wherein said benzalkonium chloride is present in an amountof from about 0.5 to about 1.5 weight percent of said composition. 20.The composition of claim 12 wherein said combination of moisturizingagents are selected from the group consisting of aloe vera, lavender andchamomile.
 21. The composition of claim 16 wherein said antibacterialagent comprises benzalkonium chloride.
 22. The composition of claim 17wherein said combination of moisturizing agents is extracts of aloe veraand chamomile.
 23. A method of cleansing an area of skin comprisingapplying the composition of claim 1 to said area of skin to be cleansed.24. The method of claim 23 wherein the composition is applied to theskin of a human.
 25. The method of claim 23 wherein the step of applyingcomprises spraying said composition on the area to be cleaned.
 26. Themethod of claim 23 wherein the step of applying comprises wetting anabsorbent medium with said composition and wiping said wet medium oversaid area.
 27. A cleansing wipe comprising the composition according toclaim 1 in combination with a medium selected from the group consistingof absorbent gauze, towelette, cloth and other fabric.